CBMS receives ninth FDA approval: the first diagnostic test for Q Fever

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The Chemical Biological Medical Systems Joint Project Management Office received its ninth Food and Drug Administration approval May 20, 2011, for the first nucleic acid amplification test to diagnose the early stages of Q fever infections in military personnel serving worldwide.

"Q fever symptoms are typical of many other infectious diseases," noted Jennifer Dabisch, Deputy Director of the CBMS Biosurveillance Joint Product Management Office (Provisional). She added, "This diagnostic test will provide a tool to diagnose the disease during the early onset of symptoms in military personnel that reside in close quarters. Currently, only serological tests are used, which are not accurate in the early stages of acute Q fever."

The U.S. Army Public Health Command initiated a Q fever surveillance program in early 2007 for this emerging infectious disease. Since then, 117 cases have been confirmed among military members serving in Iraq and Afghanistan. The bacterium that causes Q fever (Coxiella burnetii) is transmitted to humans primarily by infected livestock or exposure to contaminated environments. There is currently no human or animal licensed vaccine for Q fever available in the U.S.; however, if diagnosed early, most people with Q fever recover after treatment with appropriate medications.


The test cleared by the FDA will be used on the Department of Defense's Joint Biological Agent Identification and Diagnostic System. The JBAIDS is a diagnostic system capable of rapid, reliable, and simultaneous identification of multiple biological agents and other pathogens of concern. Through the use of this new test, the JBAIDS can now determine if the bacterium that causes Q fever is present in a person's blood sample within 4 hours. This rapid detection allows medical personnel to quickly and appropriately treat patients who are infected with Q fever. The test, developed by Idaho Technology, Inc., will only be available at military medical facilities equipped with the JBAIDS instrument.

The CBMS Joint Project Management Office, located in Frederick, Maryland, is part of the DoD's Joint Program Executive Office for Chemical and Biological Defense. Chartered in 2003, CBMS provides the Warfighter with safe, robust, affordable medical countermeasures against a broad spectrum of chemical, biological, radiological, and nuclear threats. The CBMS is composed of a headquarters and three Joint Product Management Offices: 1) the Joint Vaccine Acquisition Program, 2) the Medical Identification and Treatment Systems, and 3) Biosurveillance (provisional).

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